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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR882.4750]
See Related Information on Skull punch. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 882 -- NEUROLOGICAL DEVICES

Subpart E--Neurological Surgical Devices

Sec. 882.4750 Skull punch.

(a) Identification. A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under 882.4305.

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]

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